Common Additive To Medical Devices Puts Babies At Risk, Says EU Scientific Committee

Main Category: Medical Devices / Diagnostics
Also Included In: Pediatrics / Children's Health
Article Date: 16 Oct 2007 - 8:00 PDT

email to a friend   printer friendly   opinions  

Vulnerable groups, especially male infants, are "at risk" of suffering adverse health effects when treated with a wide range of medical devices, the EU SCENIHR Committee reported yesterday.(1)(2)

The finding is the result of a lengthy study into the safety of PVC medical devices softened with the phthalate DEHP, found in the majority of devices on the market.

Lisette van Vliet, Toxics Policy Advisor for Health Care Without Harm Europe (HCWHE), says: "The report is good because it recognises that premature babies in particular are getting very high doses of DEHP, and that these levels are so high that we should do something now, not wait for conclusive epidemiology studies that are years away."

However, HCWHE believes the study failed to address deeply enough the use of phthalates in medical devices, especially with regard to evaluation of alternatives.

"The report only evaluated the chemicals that could potentially be used to make PVC soft - it didn't evaluate any of the alternative plastics which are being used in medical devices," explains van Vliet.

"If they looked at the medical devices made from inherently soft plastics which don't need these softeners, they would have found lots of devices which don't leach toxic chemicals into patients. That would have given a more complete picture about whether or not phthalates are the kind of things we want in medical devices."(3)(4)

DEHP is of concern in medical devices because it leaches into fatty solutions such as blood and nutritional formula and is then transported directly into the patient. A number of studies have shown that DEHP has harmful effects on animals at levels equivalent to those found in neonates.

HCWH Europes's position is that hospitals should use medical devices free from plasticisers, whenever a safer alternative plastic is available. This is the only effective way to minimise patient exposure to a range of toxic and potentially-toxic chemicals present in many medical devices, because the alternative plastics do not need additives to make them soft. A number of hospitals across Europe have already phased out PVC for high-risk patient groups.(5)

Source:
Paul Whaley, Communications Coordinator, HCWH Europe
http://www.hcwh.org

Lisette van Vliet, Toxics Policy Advisor, HCWH Europe
http://www.env-health.org

Notes

(1) Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) Preliminary Report On The Safety Of Medical Devices Containing DEHP-Plasticized PVC or Other Plasticizers On Neonates and Other Groups Possibly at Risk http://ec.europa.eu...scenihr_cons_05_en.htm

(2) Report, page 43: "Data available on the exposure to DEHP show that DEHP exposure levels of neonates during certain medical procedures are in the same order of magnitude or even higher than doses inducing reproductive toxicity in animal studies. This is of concern in view of animal studies showing that immature young animals are more susceptible to testicular toxicity by DEHP than older mature animals. Neonates may therefore be considered to be at risk for the adverse reproductive and developmental effects of DEHP."

(3) A recent HCWHE survey found over 260 devices free of DEHP and other softeners available on the European market. More information here: http://www.noharm.org/details.cfm (PDF)

(4) PVC medical devices contain 20-40% of DEHP by weight. Similar amounts of alternative plasticisers are used in the alternatives mentioned in the report. SCENIHR concluded that "The information of the leaching from alternative plasticizers is sparse but may be expected to be of same order of magnitude." [page 39]

(5) Health Care Without Harm is an international network of organisations working to reduce the harm healthcare does to human health and the environment. One area of particular concern is the use of DEHP and other phthalates in medical devices. See our website: http://www.noharm.org/europe

For further information please go to:
Health Care Without Harm, Europe

• Additional
• References
• Citations